Valneva SE has announced the submission of label extension applications to the European Medicines Agency (EMA) and Health Canada, seeking to expand the use of its chikungunya vaccine, IXCHIQ, to include adolescents aged 12 to 17 years in Europe and Canada. This move aims to broaden the accessibility of the world's first and only licensed chikungunya vaccine, addressing a significant unmet medical need.
The Canadian application also incorporates two-year antibody persistence data, a key differentiator for IXCHIQ, already part of the initial EMA filing. Valneva plans to submit data to the U.S. Food and Drug Administration (FDA) later this year to support potential label extensions in the U.S.
Clinical Data Supporting Label Extension
The EMA and Health Canada applications are based on positive six-month adolescent Phase 3 data reported in May 2024. The data indicated that a single-dose vaccination with IXCHIQ induced a high and sustained immune response in 99.1% of adolescents, with the vaccine being generally well-tolerated. A recent publication in The Lancet Infectious Diseases further supported these findings, showing the vaccine was well-tolerated in adolescents aged 12 to 17 years, 28 days post-injection, regardless of previous CHIKV infection.
Antibody Persistence
Health Canada’s label extension application includes data demonstrating IXCHIQ’s antibody persistence. The data showed that the vaccine’s immune response was sustained for 24 months by 97% of participants and was equally durable in younger and older adults. Valneva anticipates publishing 36-month persistence data later in the year.
The Need for Broader Access
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, emphasized the importance of broader accessibility, stating, “Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it's imperative to ensure the vaccine is available to all age groups... This broader accessibility would certainly help provide protection and mitigate the burden of this debilitating illness which is currently spreading in areas that were previously unaffected. The durability of the immune response is also extremely important, especially for endemic countries where access to immunization can be difficult.”
About Chikungunya
Chikungunya is a mosquito-borne viral disease transmitted by infected Aedes mosquitoes. It causes fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. The joint pain can be debilitating and may persist for weeks to years. Since its re-emergence in 2004, the virus has been identified in over 110 countries across Asia, Africa, Europe, and the Americas. Between 2013 and 2023, over 3.7 million cases were reported in the Americas, with significant economic impact. The World Health Organization (WHO) has recognized chikungunya as a major public health problem, particularly as climate change expands the geographic range of mosquito vectors.
Valneva's Broader Strategy
Valneva is actively expanding the vaccine’s label and access. The company anticipates marketing authorization in Brazil in the second half of 2024 and has expanded its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to support broader access in Low Middle-Income Countries (LMICs), post-marketing trials, and potential label extensions for children, adolescents, and pregnant women. CEPI will provide Valneva up to $41.3 million over the next five years, with support from the European Union’s Horizon Europe program.
